Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients

NCT04681235 | Completed

• 1 other identifier: VR001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

In our study, we tested the hypothesis of the safe effect applicability of motor training in the immersion high-tech polymodal VR system not only on the parameters of balance, gait, and motor status of the patient, but also on his cognitive functions and mental health in patients with a degree of disability no more than 3 points on a scale Rankin.

Conditions

Stroke; Motor Disorders; Affective Symptoms; Gait Disorder, Sensorimotor

Keywords

Stroke; Virtual reality; Rehabilitation; Motion capture

Outcome Measures

Primary Outcomes (4)

• Postural stability test (Grail Motekforce)

  The subject's ability to remain balanced under four different conditions is evaluated (cm/s).

  Change from baseline at 2 weeks

• Six-minute walk test (6MWT) (Grail Motekforce)

  The 6-minute walk test evaluates how much distance a subject can cover in six minutes (m).

  Change from baseline at 2 weeks

• Beck Depression Inventory

  Measures the severity of depression (0-63; 30-63 scores indicate severe depression)

  Change from baseline at 2 weeks

• State-Trait Anxiety Inventory

  Examines two types of anxiety - state anxiety (anxiety about an event) and trait anxiety (anxiety level as a personal characteristic) with the score range from 20 to 80, where higher scores correspond to greater anxiety

  Change from baseline at 2 weeks

Secondary Outcomes (6)

• Standing Balance Test

  Change from baseline at 2 weeks

• Berg Balance Scale

  Change from baseline at 2 weeks

• Timed Up and Go Test

  Change from baseline at 2 weeks

• Hauser Ambulation Index

  Change from baseline at 2 weeks

• Rivermead Activities of Daily Living Scales

  Change from baseline at 2 weeks

Study Arms (1)

Training Group

EXPERIMENTAL

Training Group recieved 10 sessions on VR (Grail Motekforce, Netherlands) during two weeks. One session lasted 40 minuties.

Other: Training on VR

Interventions

Training on VR OTHER

The training is aimed at improving the functioning of the motor sphere, including balance, gait, and upper limb function, as well as increasing the level of motivation and reducing the level of anxiety and depression. Game applications were selected based on therapeutic tasks of motor recovery.

Training Group

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with a stroke, transferred at least 2 weeks ago; with no history of neurological or psychiatric disorders; able to maintain an upright posture and walk without support or with minimal support for at least 30 minutes; with stable hemodynamics;

You may not qualify if:

• not having epileptic activity; not having serious ophthalmic disorders; less than 24 scores in MoCA

Sponsors & Collaborators

• Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health: lead

Study Sites (1)

Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

Moscow, 117997, Russia

Location

MeSH Terms

Conditions

Stroke; Motor Disorders; Affective Symptoms; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marina A Shurupova

  Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

  PRINCIPAL INVESTIGATOR

• Alina D Aizenshtein

  Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

  PRINCIPAL INVESTIGATOR

• Galina Ivanova, Prof.

  Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

  STUDY CHAIR

• Nadezhda L Cherepahina, PhD

  Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: October 1, 2019
• Primary Completion: July 27, 2020
• Study Completion: July 27, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)